Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-11-14 to 1989-11-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to guideline but without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Delta-Valerolacton

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DR. K. THOMAE GMBH, D-7950 BIBERACH, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 172 g for males and females
- Fasting period before study: about 16 h before administration
- Housing: stainless steel wire mesh cages, type DK-III (BECKER & CO., CASTROP-RAUXEL, FRG )
- Diet (e.g. ad libitum): ad libitum (KLIBA-LABORDIAET 343, KLINGENTALMUEHLE AG CH-4303 KAISERAUGST, SWITZERLAND)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 H/12 H (6.00 - 18.00 HOURS/ 18.00 - 6.00 HOURS)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Administration volume: 10 mL/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recording of signs and symptoms several times on the day of administration. At least once each work day. Check for moribund and dead animals twice each workday and once on holidays. Weighing on days 7 and 13.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality noted.
Clinical signs:
No clinical signs noted.
Body weight:
No influence on body weight noted.
Gross pathology:
No pathologic findings noted.
Other findings:
None

Applicant's summary and conclusion